Substudy - Evaluation of Patients With Iliac Vein Thrombosis

Iliac Vein Thrombosis Clinical Trial

Official title:

Iliofemoral Thrombosis and Postthrombotic Syndrome: Registration and Analysis Within the Frankfurt Thrombophilia Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148548
• Other study ID #: ILIACA-PTS
• Status: Completed
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2019
• Source: Cardioangiologisches Centrum Bethanien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. Using standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• >18 years

• subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996

Exclusion Criteria:

• <18 years

• > 80 years

• surface or deep vein thrombosis without affection of pelvis

Related Conditions & MeSH terms

• Iliac Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Genetic:
• thrombophilia screening
genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

Locations

Country	Name	City	State
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt/Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Cardioangiologisches Centrum Bethanien

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis	The incidence and severity of postthrombotic Syndrome will be measured by te VILALLTA-Score	up to 20 years after occurrence of iliofemoral thrombosis
Secondary	Distribution of gender in Iliofemoral thrombosis	Distribution of gender (man or woman)	since 1996
Secondary	Distribution of affected side in Iliofemoral thrombosis	distribution of affected side (left or right side)	since 1996
Secondary	Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL)	A quality of life questionaire comprises 25 items that quantify disease effect on quality of life	1 year
Secondary	Incidence of venous claudication	Walking distance on treadmill	1 year